Back to resultsACTION ON COVID-19: A Study to Test Whether BI 764198 Helps Lung Health of People Hospitalised With COVID-19
Primary Purpose
COVID-19
Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
BI 764198
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for COVID-19
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 50 years
- SARS-CoV-2 infection positive confirmed by PCR or approved point-of-care test
- A score of 5 (hospitalised; oxygen by mask or nasal prongs) or 6 (hospitalised; oxygen by non-invasive ventilation or high flow), but not previously ≥7, on the WHO Clinical Progression Scale.
- Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
- Male or female patients. Women of childbearing potential (WOCBP) and men able to father a child must abstain from male female sex or must use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly during hospitalisation for at least 7 days after last trial drug intake
Exclusion Criteria:
- Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) >5 × the upper limit of normal (ULN).
- Known active infection with HIV or hepatitis B or C.
- Pulmonary oedema/respiratory failure due to cardiogenic insult.
- Previous to hospitalisation, on long-term oxygen therapy.
- A confirmed baseline prolongation of QTc interval to greater than 450 ms in males or 470 ms in females according to the Bazett formula, or any other relevant ECG finding at screening, or concomitant use of medication prolonging QT interval.
- Stage 4 severe chronic kidney disease or requiring dialysis (i.e., eGFR <30 mL/min/1.73 m2).
History of the following cardiac conditions:
- Myocardial infarction within 3 months prior to the first dose
- Unstable angina
History of clinically significant long QT features on electrocardiogram (ECG) or history of familial long QT
- Anticipated transfer/discharge to another hospital or care facility other than their place of residence
- Further exclusion criteria apply
Sites / Locations
- University of California Irvine
- Rapides Regional Medical Center
- St. Elizabeth's Medical Center
- Newton-Wellesley Hospital
- Mercy Health St. Vincent Medical Center
- Providence Regional Medical Center
- MultiCare Tacoma General Hospital
- Hospital Luxemburgo
- IPECC - Instituto de Pesquisa Clínica de Campinas
- Hospital Ernesto Dornelles
- Hospital Regional Hans Dieter Schmidt
- Hospital de Base - Fac Med de Sao Jose do Rio Preto
- Hospital Padre Alberto Hurtado
- Hospital Carlos Van Buren
- Hospital Cardiologica Aguascalientes
- Hospital General de Culiacán "Dr. Bernardo J. Gastellum"
- Hospital Universitario Dr Jose Eleuterio Gonzalez
- Hospital Auxilio Mutuo
- Hospital Municipal de San Juan
- Hospital A Coruña
- Hospital General Universitario de Alicante
- Hospital Universitario Infanta Leonor
- Hospital Clínico San Carlos
- Hospital Universitario 12 de Octubre
- Hospital Son Espases
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
BI 764198 treatment group
Placebo
Arm Description
Outcomes
Primary Outcome Measures
Percentage of Patients Alive and Free of Mechanical Ventilation
Percentage of patients alive and free of mechanical ventilation at Day 29 is presented.
One patient had no creatinine at baseline value and was therefore excluded from the statistical analysis (N=128).
Secondary Outcome Measures
Percentage of Patients Alive and Discharged Free of Oxygen Use
Percentage of patients alive and discharged free of oxygen use is presented. One patient had no creatinine at baseline value and was therefore excluded from the statistical analysis (N=128).
Percentage of Patients With Occurrence of Any Component of Composite: In-hospital Mortality or Intensive Care Unit (ICU) Admission or Mechanical Ventilation
Percentage of patients with occurrence of any component of composite: In-hospital mortality or intensive care unit (ICU) admission or mechanical ventilation is presented.
Efficacy endpoint meets when a patient has occurrence of any component of composite: In-hospital mortality or intensive care unit (ICU) admission or mechanical ventilation at Day 29.
One patient had no creatinine at baseline value and was therefore excluded from the statistical analysis (N=128).
Time to Clinical Improvement of at Least 2 Points (From Randomisation) on the World Health Organization Clinical Progression Scale, Discharge From the Hospital, or Considered Fit for Discharge
Meets when improvement of at least 2 points on World Health Organization (WHO) Clinical Progression Scale (CPS), discharge from hospital, fit for discharge (score 0, 1, 2, 3 on CPS), whichever comes first.
WHO CPS: 0. Uninfected; no viral RNA detected; 1. Asymptomatic; viral RNA detected; 2. Symptomatic; independent; 3. Symptomatic; assistance needed; 4. Hospitalised; no oxygen therapy; 5. Hospitalised; oxygen by mask or nasal prongs; 6. Hospitalised; oxygen by non-invasive ventilation or high flow; 7. Intubation + mechanical ventilation, partial pressure of oxygen/fraction of inspired oxygen (pO2/FiO2) ≥150 or oxygen saturation/FiO2 (SpO2/FiO2) ≥200; 8. Mechanical ventilation pO2/FiO2 <150 (SpO2/FiO2 <200) or vasopressors; 9. Mechanical ventilation pO2/FiO2 <150 + vasopressors, dialysis, extracorporeal membrane oxygenation (ECMO); 10. Death Only patients with event were analysed. One patient had no creatinine at baseline value, therefore excluded from statistical analysis (N=128).
Number of Ventilator Free Days
Number of ventilator free days by Day 29 is presented. One patient had no creatinine at baseline value and was therefore excluded from the statistical analysis (N=128).
Percentage of Mortality at Day 15, 29, 60 and 90
Percentage of mortality is presented. One patient had no creatinine at baseline value and was therefore excluded from the statistical analysis (N=128).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04604184
Brief Title
ACTION ON COVID-19: A Study to Test Whether BI 764198 Helps Lung Health of People Hospitalised With COVID-19
Official Title
BI 764198 Efficacy and Safety in Prevention/Progression of ARDS and ARDS-related Complications Secondary to COVID-19 (ACTION ON COVID-19)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Terminated
Why Stopped
Company decision
Study Start Date
November 3, 2020 (Actual)
Primary Completion Date
March 24, 2021 (Actual)
Study Completion Date
May 31, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boehringer Ingelheim
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study is open to adults with COVID-19 infection who are in hospital and receive oxygen. Participants need to be 50 years of age or older and need to be at risk of further worsening of their condition.
The purpose of the study is to find out whether a medicine called BI 764198 helps people with COVID-19 infection and breathing problems. BI 764198 may prevent cell death and swelling of the lung tissue and therefore help patients with COVID-19 infection.
Participants are put into 2 groups by chance. One group of participants gets BI 764198 capsules and the other group gets placebo capsules. The placebo capsules look exactly like the BI 764198 capsules but do not contain any medicine. Participants take 1 capsule per day.
Participants are in the study for about a month. At study end, doctors compare the 2 groups for the number of patients that are alive and do not need mechanical breathing support. During the study, the doctors collect information on any health problems of the participants.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
133 (Actual)
8. Arms, Groups, and Interventions
Arm Title
BI 764198 treatment group
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
BI 764198
Intervention Description
BI 764198
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Percentage of Patients Alive and Free of Mechanical Ventilation
Description
Percentage of patients alive and free of mechanical ventilation at Day 29 is presented.
One patient had no creatinine at baseline value and was therefore excluded from the statistical analysis (N=128).
Time Frame
At Day 29
Secondary Outcome Measure Information:
Title
Percentage of Patients Alive and Discharged Free of Oxygen Use
Description
Percentage of patients alive and discharged free of oxygen use is presented. One patient had no creatinine at baseline value and was therefore excluded from the statistical analysis (N=128).
Time Frame
At Day 29
Title
Percentage of Patients With Occurrence of Any Component of Composite: In-hospital Mortality or Intensive Care Unit (ICU) Admission or Mechanical Ventilation
Description
Percentage of patients with occurrence of any component of composite: In-hospital mortality or intensive care unit (ICU) admission or mechanical ventilation is presented.
Efficacy endpoint meets when a patient has occurrence of any component of composite: In-hospital mortality or intensive care unit (ICU) admission or mechanical ventilation at Day 29.
One patient had no creatinine at baseline value and was therefore excluded from the statistical analysis (N=128).
Time Frame
At Day 29
Title
Time to Clinical Improvement of at Least 2 Points (From Randomisation) on the World Health Organization Clinical Progression Scale, Discharge From the Hospital, or Considered Fit for Discharge
Description
Meets when improvement of at least 2 points on World Health Organization (WHO) Clinical Progression Scale (CPS), discharge from hospital, fit for discharge (score 0, 1, 2, 3 on CPS), whichever comes first.
WHO CPS: 0. Uninfected; no viral RNA detected; 1. Asymptomatic; viral RNA detected; 2. Symptomatic; independent; 3. Symptomatic; assistance needed; 4. Hospitalised; no oxygen therapy; 5. Hospitalised; oxygen by mask or nasal prongs; 6. Hospitalised; oxygen by non-invasive ventilation or high flow; 7. Intubation + mechanical ventilation, partial pressure of oxygen/fraction of inspired oxygen (pO2/FiO2) ≥150 or oxygen saturation/FiO2 (SpO2/FiO2) ≥200; 8. Mechanical ventilation pO2/FiO2 <150 (SpO2/FiO2 <200) or vasopressors; 9. Mechanical ventilation pO2/FiO2 <150 + vasopressors, dialysis, extracorporeal membrane oxygenation (ECMO); 10. Death Only patients with event were analysed. One patient had no creatinine at baseline value, therefore excluded from statistical analysis (N=128).
Time Frame
Up to Day 29
Title
Number of Ventilator Free Days
Description
Number of ventilator free days by Day 29 is presented. One patient had no creatinine at baseline value and was therefore excluded from the statistical analysis (N=128).
Time Frame
Up to Day 29
Title
Percentage of Mortality at Day 15, 29, 60 and 90
Description
Percentage of mortality is presented. One patient had no creatinine at baseline value and was therefore excluded from the statistical analysis (N=128).
Time Frame
At Day 15, 29, 60 and 90
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 50 years
SARS-CoV-2 infection positive confirmed by PCR or approved point-of-care test
A score of 5 (hospitalised; oxygen by mask or nasal prongs) or 6 (hospitalised; oxygen by non-invasive ventilation or high flow), but not previously ≥7, on the WHO Clinical Progression Scale.
Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
Male or female patients. Women of childbearing potential (WOCBP) and men able to father a child must abstain from male female sex or must use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly during hospitalisation for at least 7 days after last trial drug intake
Exclusion Criteria:
Alanine aminotransferase (ALT)/aspartate aminotransferase (AST) >5 × the upper limit of normal (ULN).
Known active infection with HIV or hepatitis B or C.
Pulmonary oedema/respiratory failure due to cardiogenic insult.
Previous to hospitalisation, on long-term oxygen therapy.
A confirmed baseline prolongation of QTc interval to greater than 450 ms in males or 470 ms in females according to the Bazett formula, or any other relevant ECG finding at screening, or concomitant use of medication prolonging QT interval.
Stage 4 severe chronic kidney disease or requiring dialysis (i.e., eGFR <30 mL/min/1.73 m2).
History of the following cardiac conditions:
Myocardial infarction within 3 months prior to the first dose
Unstable angina
History of clinically significant long QT features on electrocardiogram (ECG) or history of familial long QT
Anticipated transfer/discharge to another hospital or care facility other than their place of residence
Further exclusion criteria apply
Facility Information:
Facility Name
University of California Irvine
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Rapides Regional Medical Center
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71301
Country
United States
Facility Name
St. Elizabeth's Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Newton-Wellesley Hospital
City
Newton
State/Province
Massachusetts
ZIP/Postal Code
02462
Country
United States
Facility Name
Mercy Health St. Vincent Medical Center
City
Toledo
State/Province
Ohio
ZIP/Postal Code
43608
Country
United States
Facility Name
Providence Regional Medical Center
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
MultiCare Tacoma General Hospital
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Hospital Luxemburgo
City
Belo Horizonte
ZIP/Postal Code
32380-490
Country
Brazil
Facility Name
IPECC - Instituto de Pesquisa Clínica de Campinas
City
Campinas
ZIP/Postal Code
13060-080
Country
Brazil
Facility Name
Hospital Ernesto Dornelles
City
Porto Alegre
ZIP/Postal Code
90160-092
Country
Brazil
Facility Name
Hospital Regional Hans Dieter Schmidt
City
Santa Catarina
ZIP/Postal Code
89227
Country
Brazil
Facility Name
Hospital de Base - Fac Med de Sao Jose do Rio Preto
City
Sao Jose do Rio Preto
ZIP/Postal Code
15090-000
Country
Brazil
Facility Name
Hospital Padre Alberto Hurtado
City
Santiago
ZIP/Postal Code
8880465
Country
Chile
Facility Name
Hospital Carlos Van Buren
City
Valparaiso
ZIP/Postal Code
2341131
Country
Chile
Facility Name
Hospital Cardiologica Aguascalientes
City
Aguascalientes
ZIP/Postal Code
20230
Country
Mexico
Facility Name
Hospital General de Culiacán "Dr. Bernardo J. Gastellum"
City
Culiacán
ZIP/Postal Code
80230
Country
Mexico
Facility Name
Hospital Universitario Dr Jose Eleuterio Gonzalez
City
Monterrey
ZIP/Postal Code
64460
Country
Mexico
Facility Name
Hospital Auxilio Mutuo
City
Hato Rey
ZIP/Postal Code
00919
Country
Puerto Rico
Facility Name
Hospital Municipal de San Juan
City
Rio Piedras
ZIP/Postal Code
00936
Country
Puerto Rico
Facility Name
Hospital A Coruña
City
A Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital Universitario Infanta Leonor
City
Madrid
ZIP/Postal Code
28031
Country
Spain
Facility Name
Hospital Clínico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Son Espases
City
Palma de Mallorca
ZIP/Postal Code
07120
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
The data shared are the raw clinical study data sets.
IPD Sharing Time Frame
After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
IPD Sharing Access Criteria
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
IPD Sharing URL
https://www.mystudywindow.com/msw/datasharing
Links:
URL
https://www.mystudywindow.com/
Description
Related Info
Learn more about this trial
ACTION ON COVID-19: A Study to Test Whether BI 764198 Helps Lung Health of People Hospitalised With COVID-19
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